Orthophos 5/Plus/Cd
510(k) K983057
Orthophos 5/Plus/Cd is a Class II device made by SIRONA Dental Systems GmbH, cleared under FDA 510(k) K983057 on 22 Oct 1998, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983057 | Date22 Oct 1998 | StatusActive |
Official records
- FDA 510(k) database K983057
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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